{"id":57345,"date":"2022-05-24T10:10:54","date_gmt":"2022-05-24T08:10:54","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/apercu-de-la-qualification-et-de-la-validation\/"},"modified":"2022-05-24T10:10:54","modified_gmt":"2022-05-24T08:10:54","slug":"apercu-de-la-qualification-et-de-la-validation","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/apercu-de-la-qualification-et-de-la-validation\/","title":{"rendered":"Aper\u00e7u de la qualification et de la validation"},"content":{"rendered":"<p>Dans la fabrication de produits <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/pharmaceutique\/\">pharmaceutiques<\/a> et de <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/dispositifs-medicaux\/\">dispositifs m\u00e9dicaux<\/a>, la qualit\u00e9 des produits et la s\u00e9curit\u00e9 des patients ne sont pas des objectifs ambitieux, ce sont des <a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations\">exigences r\u00e9glementaires<\/a>. Ce cours d\u2019introduction couvre les principes fondamentaux de la qualification et de la validation dans le cadre des <a href=\"https:\/\/gxp-training.com\/online-course\/cfrs-part-210-and-211-online-certified-course-training\/\">Bonnes Pratiques de Fabrication actuelles<\/a> (BPFc). <\/p>\n<p>Apr\u00e8s avoir r\u00e9ussi le cours, vous recevrez un <strong>certificat valid\u00e9 accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, reconnu \u00e0 des fins d\u2019audit et de conformit\u00e9.<\/p>\n<p><strong>Qui devrait s\u2019inscrire ?<\/strong><\/p>\n<ul>\n<li>Professionnels de l\u2019<a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/assurance-qualite\/\">assurance qualit\u00e9<\/a> et du contr\u00f4le qualit\u00e9<\/li>\n<li>Personnel de fabrication et d\u2019ing\u00e9nierie des processus<\/li>\n<li>Professionnels des <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/affaires-reglementaires\/\">affaires r\u00e9glementaires<\/a><\/li>\n<li>Professionnels d\u00e9butant dans la validation et recherchant un aper\u00e7u fondamental structur\u00e9<\/li>\n<\/ul>\n<p><strong>Ce que vous apprendrez :<\/strong><\/p>\n<ul>\n<li>La d\u00e9finition et les principes fondamentaux de la validation dans le cadre des BPFc<\/li>\n<li>Les principaux types de validation : prospective, concurrente, r\u00e9trospective et revalidation<\/li>\n<li>La structure et l\u2019objectif d\u2019un Plan Directeur de Validation (PDV)<\/li>\n<li>Les trois \u00e9tapes de la <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/process-validation-general-principles-and-practices\">validation des processus<\/a> : conception, qualification et v\u00e9rification<\/li>\n<li>Exigences de validation pour le nettoyage, les syst\u00e8mes informatis\u00e9s et les m\u00e9thodes analytiques<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p><strong>Introduction<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : D\u00e9finition de la validation<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : N\u00e9cessit\u00e9 de la qualification et de la validation des processus<\/strong><\/p>\n<p><strong>Le\u00e7on 3 : Port\u00e9e de la validation<\/strong><\/p>\n<ul>\n<li>Importance de la validation<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 4 : Principaux avantages de la validation<\/strong><\/p>\n<ul>\n<li>Assurance qualit\u00e9<\/li>\n<li>Optimisation des processus<\/li>\n<li>R\u00e9duction des co\u00fbts de qualit\u00e9<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 5 : Types\/M\u00e9thodes de validation<\/strong><\/p>\n<ul>\n<li>Validation prospective<\/li>\n<li>Validation concurrente<\/li>\n<li>Validation r\u00e9trospective<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 6 : Activit\u00e9s \u00e0 entreprendre avant de commencer un projet de validation<\/strong><\/p>\n<ul>\n<li>Le Comit\u00e9 de Validation<\/li>\n<li>\u00c9valuation des processus pour d\u00e9terminer les exigences de validation<\/li>\n<li>Identification des syst\u00e8mes et des limites du syst\u00e8me<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 7 : Plan Directeur de Validation<\/strong><\/p>\n<ul>\n<li>Plan Directeur de Validation<\/li>\n<li>Contenu du PDV<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 8 : Concept de base de la validation des processus<\/strong><\/p>\n<ul>\n<li>Qualification de l\u2019installation (QI)<\/li>\n<li>Qualification op\u00e9rationnelle (QO)<\/li>\n<li>Qualification de la performance (QP)<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 9 : Les \u00e9tapes de la validation des processus<\/strong><\/p>\n<ul>\n<li>\u00c9tape 1 \u2013 Conception du processus<\/li>\n<li>\u00c9tape 2 \u2013 Validation ou qualification du processus<\/li>\n<li>\u00c9tape 3 \u2013 V\u00e9rification continue du processus<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 10 : Rapport de protocole de validation<\/strong><\/p>\n<p><strong>Le\u00e7on 11 : <a href=\"https:\/\/gxp-training.com\/online-course\/cleaning-validation-course\/\">Validation du nettoyage<\/a><\/strong><\/p>\n<ul>\n<li>Choix de la m\u00e9thode de nettoyage<\/li>\n<li>Mesure du niveau de propret\u00e9<\/li>\n<li>D\u00e9finition des limites<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 12 : <a href=\"https:\/\/gxp-training.com\/online-course\/computer-system-validation-csv\/\">Validation des syst\u00e8mes informatis\u00e9s<\/a><\/strong><\/p>\n<ul>\n<li>\u00c9valuation des syst\u00e8mes informatis\u00e9s pour d\u00e9terminer les exigences de validation<\/li>\n<li>Mat\u00e9riel (Hardware)<\/li>\n<li>Logiciel (Software)<\/li>\n<\/ul>\n<p><strong>Le\u00e7on 13 : Validation des m\u00e9thodes analytiques<\/strong><\/p>\n<ul>\n<li>Contr\u00f4le des changements et revalidation<\/li>\n<li>Revalidation<\/li>\n<\/ul>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>Quiz<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dans la fabrication de produits pharmaceutiques et de dispositifs m\u00e9dicaux, la qualit\u00e9 des produits et la s\u00e9curit\u00e9 des patients ne sont pas des objectifs ambitieux, ce sont des exigences r\u00e9glementaires. Ce cours d\u2019introduction couvre les principes fondamentaux de la qualification et de la validation dans le cadre des Bonnes Pratiques de Fabrication actuelles (BPFc). Apr\u00e8s [&hellip;]<\/p>\n","protected":false},"featured_media":44163,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[257,254,264],"product_tag":[],"class_list":{"0":"post-57345","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-assurance-qualite","7":"product_cat-bpf-bonnes-pratiques-de-fabrication","8":"product_cat-transversal","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Qualification et validation des processus : Cours certifi\u00e9 en ligne<\/title>\n<meta name=\"description\" content=\"Ce cours enseigne la pertinence des mesures de qualification et de validation pour la fabrication et la recherche. 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